The Indian pharma, which has been receiving clearances for its Abbreviated New Drug Applications (ANDAs) from the US FDA, now views the recently issued norms of the US regulator on ANDA stability data recommendations in a question and answer format as a convenient reference information during their submissions.
Going by the increasing ANDAs submissions by companies in India which include Natco, Biocon, Glenmark, Sun Pharma and Strides Arcolab to name a few, there are always doubts and queries which require well-structured clarifications. This is where the recent US FDA guidance on stability testing data recommendations for ANDAs is much appreciated by the Indian pharma companies.
An ANDA submission contains the data for the approval of a generic drug. “The new norms issued by US FDA is seen to provide better clarity in terms of compliance and will speed up the process of approval" said Kaushik Desai, honorary general secretary, Indian Pharmaceutical Association (IPA).
In 2013, India received approvals for 200 ANDAs. These include companies like Aurobindo, Dr Reddy’s Labs, Lupin, Jubilant Life Sciences, Sun Pharma , Indoco Remedies, Ranbaxy and Strides Arcolab. In early 2014, Natco received tentative approval for its ANDA on a Tamilflu generic. Sun Pharma got an ANDA nod for its generic version of Tenodar prescribed for glioblastoma. Glenmark received ANDA for a dermatology topical application. Now with a strong focus for generic drug prescriptions from the governments of US, European Union and Japan, there are many Indian companies exporting to these markets.
According to Interlink Knowledge Cell, each ANDA application submission involved considerable time and effort.
The US regulatory authority in its new guidance has devised five sections covering general information on submissions of drug master files (DMFs), drug product manufacture & packaging amendments, to information on handling the pending ANDA applications and stability studies. Each of these sections has a comprehensive presentation of queries and responses which a pharma company can refer to at any point of time.
The questions and answers provided by US FDA range from the scope and implementation date for the stability guidance. It also deals with how the guidance focuses on ANDAs coming under the President’s Emergency Plan for AIDS Relief (PEPFAR) and positron emission tomography (PET) generic drugs.
The FDA has clearly indicated the guidance for industry on fixed dose combinations, co-packaged drug products, and single-entity versions of previously approved anti-retrovirals for the treatment of HIV.
On whether an ANDA needs to be submitted within six months of accelerated stability and six months of long-term stability data, the regulator has pointed out the need for accelerated stability data. In the case of significant change or failure of any attribute, the applicant should also submit 6 months of intermediate data at the time of submission.
To a query on whether two lots of finished product at pilot scale batch size be considered sufficient to support the stability of an ANDA for simple dosage forms, FDA stated that the applicant should submit data from three pilot scale batches or should submit data from two pilot scale batches and one small scale batch.
In addition, the regulatory authority has focused on the proposed shelf life calculation and on the pilot scale batches, submitted as a part of an ANDA, need to be stored before destruction.